AMS DSAEK Pack Convenience Kit
Windstone recalls AMS DSAEK Pack kits (Part AMS12394B) due to detached blue BOPs in saline bags.
Do not use the affected convenience kit. Contact Windstone Medical Packaging for instructions on returning the product and obtaining a replacement.
Recall at a glance
- Quantity recalled
- 3,260 kits
Why it was recalled
Windstone Medical Packaging is recalling the AMS Convenience Kit: DSAEK Pack - RX, Part Number AMS12394B, because the kit contains 0.9% Sodium Chloride Injection, USP in Single Dose freeflex bags that may have blue Break-off-Parts (BOPs) detached from the infusion port during manipulation. The presence of detached BOPs could lead to contamination or particulate introduction, posing a risk of patient harm.
Is mine affected?
Check the model, lot, or serial number on the device or its packaging. Yours is affected if it matches one below.
AMS Convenience Kit
- Lot code
- 241907, 241223, 241034, 240904, 240705, 240633, 240269, 238361, 238197, 238146, 238085, 238084, 238041, 237957, 237901, 237843, 237663, 237444, 237443, 236863, 236740, 236250, 236249, 236111, 235602, 235601, 235442, 235026, 235025, 235024, 235023, 234889, 234839, 234458, 233931, 233930, 233762, 233328, 233224, 231945 (+43 more, see the official notice)
- UDI-DI
- B098AMS12394B0
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other recent recalls from Windstone Medical Packaging, Inc.
Editorial summary by Recall Canary · summary updated 2026-09-11 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification